BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3870910 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85711
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. NO PRIME ALARM NOTED. THE INSULIN PUMP RECEIVED WITH SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER'S FAMILY OR FRIEND CALLED IN TO REPORT INSULIN SQUIRTING OUT OF INSULIN PUMP DURING MANUAL PRIMING PROCESS AND DEVICE IS ALARMING. BLOOD GLUCOSE LEVEL WAS 186 MG/DL AT TIME OF REPORTING. CUSTOMER STATED DRIVE SUPPORT CAP HAD PREVIOUSLY BEEN PROTRUDING AND HAD BEEN PRESSED BACK IN. ADVISED CUSTOMER TO DISCONTINUE USE AND REVERT TO HEALTHCARE PROVIDERS INSTRUCTIONS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347025 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR